Multiple Sclerosis Clinical Trial

Assessment of tDCS-Induced Neuronal Responses in Multiple Sclerosis (MS) With Advanced MRI

Summary

The objective of this trial is to measure the changes in neural activities during tDCS session using Magnetic Resonance Imaging (MRI). Participants (N=60) (20 Healthy Controls and 40 participants with neurological disorders, ie. multiple sclerosis) will be recruited to complete self-report measures and a brief cognitive assessment and then undergo an hour long stand-alone MRI scan while simultaneously undergoing tDCS stimulation. Methodology for this study is the administration of 15-minutes of of active tDCS during MRI acquisition compared to time without active tDCS.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for MS Patients:

Participants must be 18 years of age or older
Standardized SDMT Z-score > - 3.0
Fatigue Severity Scale score > 36
Definite MS diagnosis as assessed by licensed physician any subtype including Relapsing Remitting (RRMS), Primary Progressive (PPMS) or Secondary Progressive (SPMS)
Score of ≤ 7.0 on the Expanded Disability Status Scale
Clinically stable without disease progression in the past 3 months
Has stable and continuous access to internet service at home compatible with the study laptop (Wi-Fi or Ethernet cable)
Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/
Adequate home facilities (enough space, access to quiet and distraction free area)
Able to commit to the four-week period of training sessions with baseline and two follow-up visits

Exclusion Criteria for MS Patients:

Extreme claustrophobia
Relapse or steroid use in previous month
History of mental retardation, pervasive developmental disorder, or other neurological condition associated with cognitive impairment
Primary psychiatric disorder that would influence ability to participate
Current uncontrolled seizure disorder
Current substance abuse disorder
Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
Treatment for a communicable skin disorder currently or over the past 12 months
Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
Pregnant or breastfeeding
Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition Scaled Score < 85
Beck Depression Inventory - Fast Screen (BDI-FS) score > 9

Inclusion Criteria for Healthy Controls:

Participants must be 18 years of age or older
Standardized SDMT Z-score > - 3.0
Have not been diagnosed with MS or other neurological disorder
Adequate internet capacity for remote monitoring, as tested by http://www.speedtest.net/ (HC subgroup only)
Adequate home facilities including enough space, access to quiet and distraction free area (HC subgroup only)
Able to commit to the four-week period of training sessions with baseline and one follow-up visit (HC subgroup only)

Exclusion Criteria for Healthy Controls:

Extreme claustrophobia
History of mental retardation, pervasive developmental disorder or other neurological condition associated with cognitive impairment
Primary psychiatric disorder that would influence ability to participate
Current uncontrolled seizure disorder
Current substance abuse disorder
Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
Treatment for a communicable skin disorder currently or over the past 12 months
Have any irremovable piercings, MRI-contraindicated implantations or metallic based-tattoos
Pregnant or breastfeeding

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

73

Study ID:

NCT03564496

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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New York University School of Medicine
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

73

Study ID:

NCT03564496

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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